Drug sponsors request FDA to withdraw drug application approval

The U.S. Food and Drug Administration has announced that five drug sponsors holding animal drug applications affected by Guidance For Industry (GFI) #213 have requested that FDA withdraw approval of a collective 19 animal drug applications because the products are no longer manufactured or marketed. Of these 19 applications, 16 are antimicrobials affected by GFI #213.
The guidance outlines FDA's plan to help curb antimicrobial resistance by, among other things, phasing out the use of medically important antimicrobials in food-producing animals for production purposes.
The following companies have requested that FDA withdraw approval for their listed products:
ADM Alliance Nutrition Inc.
• Gilt Edge TYLAN (tylosin phosphate) Mix
• HFA Tylosin-10 Plus Sulfa (tylosin phosphate and sulfamethazine)
• Good Life TYLAN 10 (tylosin phosphate) Premix
• HFA HYGROMIX 0.48 (hygromycin B) Medicated Premix
• TYLAN 5 Sulfa (tylosin phosphate and sulfamethazine) Premix
Micro Beef Technologies LTD
• TYLAN 40 or 100 (tylosin phosphate)
Ridley Feed Ingredients
• Waynextra for Swine (tylosin phosphate)
• TYLAN Sulfa-G (tylosin phosphate and sulfamethazine)
• Ban-A-Worm II (pyrantel tartrate)
Provimi North America Inc.
• TYLAN 5, 10, 20, or 40 (tylosin phosphate)
• WORM-BAN 5 or 10 (pyrantel tartrate)
• HYGROMIX 0.6 (hygromycin B)
• FLAVOMYCIN 0.4 or 2 (bambermycins)
• STAFAC 10 (virginiamycin)
Virbac AH Inc.
• PURINA HYGROMIX (hygromycin B) for Swine
• PURINA Pork-Plus (tylosin phosphate and sulfamethazine)
• PURINA Hog Plus II (tylosin phosphate)
• PURINA TYLAN 40 (tylosin) Plus Sulfamethazine
• PURINA Check-R-Ton Ll. (lincomycin hydrochloride)